The Internal Quality Control for TEST 1, the Automatic Analyzer of Erythrocyte Sedimentation Rate

ESR 자동분석기를 이용한 내부정도관리방법

Recently automatic equipment has been well popularized for the erythrocyte sedimentation rate, a widely used test, but no standard quality control has been established yet. Thus, we are going to report a case that established and applied a quality control method using the TEST 1 automatic analyzer. For internal quality control, we adopted the repeatability test through comparison with daily mean check, with a manual method using patients' specimens and with the results of a test on the previous day. In order to set the tolerance standard for each quality control method, we compared the results of 50 specimens that showed a wide range of ESR results and examined correlation and differences according to result. After setting the tolerance standard, we applied the standard at tertiary university hospitals for 120 days and investigated positive rates and re-examination rates. If the tolerance standard was exceeded, the cause was also identified. We selected a specimen of below 25 mm/hr (T1), one between 26-50 mm/hr (T2) and one of over 51 mm/hr (T3) at random. The correlation between the manual method and the automatic method was quite high (r=0.98), and it is found appropriate to set based on differences in result values below 25 mm/hr, the upper limit of the reference value, and based on differences in the percentage of result values above 25 mm/hr. Accordingly, we set the criteria for rejection above 10 mm/hr and above 20%. When the criteria were applied in the laboratory, 1.7% of specimens in the range of T1, 8.3% of those in the range of T2 and 7.5% of those in the range of T3 were rejected. Because all the rejected ones fell within the tolerance limit in re-examination calibration verification was not carried out. With the wide popularization of erythrocyte sedimentation rate analyzers that can carry out a lot of tests quickly using automatic methods, it is necessary to improve the reliability of test results by establishing internal quality control policies. We expect that an agreed standard quality control method may be established based on the method proposed in this study.